Since June 2005, Indianapolis-based Guidant Corporation has recalled thousands of its pacemakers and defibrillators. According to Harvard Medical School, the recalls signal a larger, more troubling trend: A steady increase in malfunctions that has gone largely unnoticed by government regulators.
For 30 years, the Raleigh defective medical device lawyers of Hardison & Cochran have defended those injured or killed because of dangerous medical devices. We know that the success of each case depends upon the network of experts in the medical and legal field who can work with a firm and the case during its investigation and handling of the claim. We have made sure our network of experts is available to assist you in the pursuit of your defective device claim.
On July 18, 2005 Guidant Corporation alerted doctors that nine pacemaker models made from 1997 to 2000 might need to be replaced. An estimated 28,000 of the pacemakers remain implanted in patients worldwide, with about 18,000 of those in U.S. patients. This warning was issued just one month after the company recalled almost 109,000 of its defibrillators.
According to Guidant Corp., a sealing component in the pacemakers had degraded in some cases, resulting in higher-than-normal moisture in the devices that could cause a malfunction. Because of this, several patients had lost consciousness or developed possible heart failure. The company reported the death of one person whose pacemaker might have failed.
The pacemakers affected by the notification were:
- PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
- CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
- CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
Guidant told physicians to consider replacing the affected pacemakers in patients who depend on them for survival, or roughly 20 to 40 percent of pacemaker patients. The company said it would pay for the replacements at no charge through the end of 2005, whether or not the warranty has expired. Guidant stated it would also reimburse patients up to $2,500 for medical expenses.
The company said it had identified 69 failures among the pacemakers after each had been used for at least 44 months. The models are: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and Contak TR.
Guidant also informed the Food and Drug Administration that it is recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance.
The Guidant defibrillators are implanted into the chest cavity of patients and are intended to monitor irregularities in heart rhythm (arrhythmia). When functioning properly the units can detect when the heart is beating out of rhythm, and deliver a series of electrical shocks to correct the arrhythmia.
Guidant Corp. has said that the devices have malfunctioned at least 45 times, causing two deaths. The malfunction that is the subject of the recall causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. Guidant recently conceded that it waited three years before telling doctors and patients about the electrical defect.
If you have one of the recalled Guidant defibrillators or pacemakers, contact your doctor immediately to discuss your medical options. The FDA is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced. This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.
The Raleigh defective medical device attorneys at Hardison & Cochran are representing patients and families who have been harmed by a malfunction of Guidant defibrillators and pacemakers. If you feel you have been harmed due to use of Guidant medical devices, contact our firm today at (800) 434-8399 or through our online form for a FREE case review.